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Gilead patent case to help Indian firms

NEW DELHI: The US Patent & Trademark Office’s rejection of four patents held by Gilead Sciences on a key HIV drug Tenofovir, paves the way for a more affordable treatment for millions of patients suffering from AIDS.

The US patent office decision strengthens the pre-grant opposition filed in 2006 by Indian Network for People Living with HIV/AIDS (INP+) to several patent applications filed by Gilead on tenofovir disoproxil fumarate (TDF) in India, on the ground that they did not meet the country’s patentability standards.

For the domestic generic industry, the development encourages production of the drug in the country, and gives them opportunities to export to developing countries.

US public interest organization, Public Patent Foundation (PUBPAT) challenged the patents in the US patent office, saying that Gilead’s patent on TDF did not fulfil the criteria of novelty.

With this rejection, Gilead Sciences faces an uphill task to get a patent in India, and other developing countries. Legal experts say, Gilead will now have to share this information with the Indian patent office, which is in the process of examining patent applications on TDF by Gilead.

TDF is important for people suffering with AIDS as a first line treatment, and also for those who have developed resistance to first-line antiretroviral therapy. WHO treatment guidelines include TDF in first and second-line antiretroviral regimens.

INP+, which filed a pre-grant opposition in India is concerned that if patents on TDF are granted access to affordable generic versions of the drug will be affected. Patents granted on TDF by other countries denied people living with HIV/AIDS access to this important anti-retroviral. In fact, Brazil who has granted the patents on TDF has not been able to produce the generic version and has been forced to pay high prices to Gilead to provide the drug to its patients.

The lowest price that Gilead offers TDF (300 mg) in Brazil is $2766 per patient per year, which was nearly halved at $1400 after it threatened invoking a compulsory licence.

The cost of treatment would be one-seventh of that price, if an Indian generic such as Hetero Drugs, Cipla and Matrix offers the drug — at $195 per patient per year.